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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V2
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at olympus service operation repair center, it was found that foreign matter came out from the instrument channel.The subject device had been returned to sorc for repair because the instrument channel had been clogged with calculus.The occurrence date of the event is unknown.There was no report of patient injury associated with the event.
 
Manufacturer Narrative
The subject device was not returned to omsc for evaluation but was returned to olympus service operation repair center (sorc).Sorc checked the subject device and found the reported phenomenon.The exact cause of the reported event could not be conclusively determined.However, based upon the information from sorc, omsc surmised that the reported phenomenon was attributed to the insufficient reprocessing and/or the user handling.If additional information is received, this report will be supplemented.
 
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Brand Name
URETERO-RENO VIDEOSCOPE
Type of Device
URETERO-RENO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key12566519
MDR Text Key280534217
Report Number8010047-2021-12600
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 10/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberURF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2021
Was the Report Sent to FDA? No
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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